Overcoming the challenge of changing regulations Brenna Boonstra - - PowerPoint PPT Presentation

NHP/FI Building Success Conference

A Reality Check: Overcoming the challenge of changing regulations

Brenna Boonstra

Regulatory Affairs Manager, NHP Consulting Inc.

Source: https://www.chfa.ca/files/regulatory_files/CHFA_Tradeshows/CHFA_East_Regulatory_Forum_SFCR.pdf

Current state of the dynamic regulations

Regulatory Compliance, in all cases

• Responsibilities of the

manufacturer/importer:

– Safety/quality of product – Accurate positioning in the marketplace – Conform with applicable regulations – All food/supplement businesses should have awareness

Product Classification

• Classification of a product drives regulatory

requirements (how and when you can sell)

• Products can fit in more than one category

Especially true for functional foods (“food-like NHPs”)

• Novel food
• Compliant food
• Non-compliant food
• Supplemented food
• Natural health product
• Food can be medicine, but the regulations differ.

Health Canada guidance: http://www.hc-sc.gc.ca/dhp- mps/prodnatur/legislation/docs/food-nhp-aliments-psn-guide-eng.php

The first step in classification: (1) Product Composition

– All ingredients are considered – Food ingredients – Non-food ingredients – Added amino acids, vitamins, minerals – Novel ingredients – Additives

Permitted Food Additives

Health Canada reference: http://www.hc-sc.gc.ca/fn-an/securit/addit/list/index-eng.php

Classification: (2) Product representation

• Positioning

– Health (therapeutic) claims? – Nutrition, satisfying hunger, thirst, desire for flavour?

• Directions of use
• Point(s) of sale

Classification: (3) Product format

• Food-Like format  Food
• Beverages, candies, bars
• Pharmaceutical/cosmetic format  Not a food
• Capsules, tablets, creams, lotions
• Powders, liquids  Ambiguous

Classification: (4) Public perception and history of use

• Historical pattern of use as food or

therapeutic product

• Ready to drink liquids above/below 90

mL packages

Classification: (5) Owner preference and flexibility

• Sometimes more than one regulatory path is

available

• Flexibility in formulation, marketing, packaging
• ffers choice
• Knowledge of regulations allows conscious

choices in composition, representation, brand name, and format of your products that can affect how your products are regulated

Example: Coffee + Reishi Mushroom

• Ingredients
• Coffee bean
• Reishi mushroom
• Acesulfame-K
• Classification

– Composition – History of use – Format – Representation – Owner preference

The categories: Compliant Food

• All acceptable food ingredients

– Minimal processing – History of safe use as a food – Serve food purposes

• Nourishment/Nutrition
• Hydration
• Satisfy hunger/thirst
• Desire for taste, texture, flavour
• All permitted Food Additives

Apply: Compliant Food

• Simplest from a regulatory perspective
• No pre-market approval required
• No facility registration required, though this will

be changing

• Prescriptive composition
• Limited claims

– Nutrient-Function

• Nutrient-Content

– General Health

• Function

– Disease risk reduction

• Limited therapeutic

Regulations and Guidance: Compliant Foods

• Canadian Food Inspection Agency

http://www.inspection.gc.ca/about-the-cfia/acts-and-regulations/list-of-acts-and-regulations/eng/1419029096537/1419029097256

• Health Canada

http://www.hc-sc.gc.ca/ahc-asc/legislation/acts-reg-lois/acts-reg-lois-eng.php

• Food and Drugs Act
• Food and Drug Regulations (FDR)
• Safe Food For Canadians Act (SFCA)
• Consumer Packaging and Labelling Act
• Food Labelling Guidance:

http://www.inspection.gc.ca/food/labelling/food-labelling-for- industry/eng/1383607266489/1383607344939

• Nutrient Function Claims

http://inspection.gc.ca/food/labelling/food-labelling-for-industry/health- claims/eng/1392834838383/1392834887794?chap=8

• Therapeutic Claimshttp://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/assess-evalu/index-eng.php

The categories: Non-compliant Food

• Some aspect outside the FDR

– New ingredient – Added vitamins, minerals, amino acids – New additive

• Supplemented foods often fall into this

category

• “Non-compliant” food doesn’t mean the

product can never be sold, but additional regulatory steps are required

Apply: Non-compliant Food

• Pre-market steps required
• Temporary Marketing Authorization Letter (TMAL)
• Novel food submission
• Food additive submission
• Limited claims
• Prescriptive composition
• Can be reformulated into compliant

foods to facilitate immediate market access

Regulations and Guidance: Non-Compliant Foods

• Canadian Food Inspection Agency

http://www.inspection.gc.ca/about-the-cfia/acts-and-regulations/list-of-acts-and-

regulations/eng/1419029096537/1419029097256

• Health Canada

http://www.hc-sc.gc.ca/ahc-asc/legislation/acts-reg-lois/acts-reg-lois-eng.php

• Food and Drugs Act
• Food and Drug Regulations (FDR)
• Safe Food For Canadians Act (SFCA)
• Consumer Packaging and Labelling Act
• Food Labelling Guidance:

http://www.inspection.gc.ca/food/labelling/food-labelling-for- industry/eng/1383607266489/1383607344939

• TMAL Guidance:

http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/food-market-author-marche-aliment-eng.php

• Nutrient Function Claims

http://inspection.gc.ca/food/labelling/food-labelling-for-industry/health- claims/eng/1392834838383/1392834887794?chap=8

• Therapeutic Claimshttp://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/assess-evalu/index-

eng.php

Example: Super Cranberry

• Classification

– Composition – Representation – Format – History of use – Owner preference

The categories: Natural Health Product

• Pharmaceutical format
• Therapeutic claims
• Non-food ingredients
• Specific directions of use
• Risk information
• Ingredients recognized by NNHPD

Natural Health Products Ingredients Database

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do

Apply: Natural Health Product

• Pre-market approval required

– Claims – Formula – Directions of use

• Site licensing

– Facility registration – Finished product (quality) testing

• Regulatory Tool: Monographs

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monosReq.d%3Flang=eng

Regulations and Guidance: Natural Health Products

• Natural and Non-Prescription Health Products Directorate

(NNHPD) – Health Canada

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php

• Natural Health Product Regulations (NHPR)
• Food and Drugs Act
• Food and Drug Regulations (FDR)
• Safe Food For Canadians Act (SFCA)
• Consumer Packaging and Labelling Act
• NHP Labelling Requirements Checklist

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/label-list-etiquet-eng.php

• Quality of Natural Health Products Guide

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq-eng.php

• Site Licensing

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.php

Example: Energy Drink

• Ingredients:

– Carbonated water – Whey protein – Acesulfame potassium – FD&C Red #40 – Green Tea – Vitamin B12 – Taurine – Caffeine

• Classification

– Composition – Representation – Format – History of use – Owner preference

Contact: Brenna Boonstra brenna@nhpconsulting.ca